Head and Shoulders

Product NDC: 37000-341
11-digit product format: 370000341
Labeler code: 37000
Product ID: 37000-341_dc66d6b2-d081-5048-e053-2a95a90ae57d
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrithione Zinc
Dosage form: LOTION/SHAMPOO
Route: TOPICAL
Labeler: The Procter & Gamble Manufacturing Company
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-09-01
Marketing end: 2022-08-14
Substance: PYRITHIONE ZINC
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	37000-341		D	Discontinued by firm	2026-10-05
excluded package	package	37000-341	37000-341-10	D	Discontinued by firm	2026-10-05
excluded package	package	37000-341	37000-341-23	D	Discontinued by firm	2026-10-05
excluded package	package	37000-341	37000-341-38	D	Discontinued by firm	2026-10-05
excluded package	package	37000-341	37000-341-66	D	Discontinued by firm	2026-10-05
excluded package	package	37000-341	37000-341-93	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 81 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-341-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-341-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-341-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-341-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-341-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-341-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-341-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-341-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-341-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-341-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-341-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-341-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-341-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-341-93	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-341-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-341-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-341-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-341-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-341-93	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-341-66	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-341-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-341-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-341-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-341-93	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-341-66	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-341-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-341-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-341-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-341-93	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-341-66	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-341-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-341-38	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-341-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-341-93	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-341-66	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-341-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-341-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-341-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-341-93	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-341-66	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-341-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-341-38	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-341-23	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-341-93	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-341-66	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-341-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-341-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-341-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-341-93	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-341-66	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
37000-341-10	2022-04-11	Head and Shoulders ® Instant Relief
37000-341-23	2022-04-11	Head and Shoulders ® Instant Relief
37000-341-38	2022-04-11	Head and Shoulders ® Instant Relief
37000-341-66	2022-04-11	Head and Shoulders ® Instant Relief
37000-341-93	2022-04-11	Head and Shoulders ® Instant Relief
37000-341-10	2021-01-29	Head and Shoulders ® Instant Relief
37000-341-23	2021-01-29	Head and Shoulders ® Instant Relief
37000-341-38	2021-01-29	Head and Shoulders ® Instant Relief
37000-341-66	2021-01-29	Head and Shoulders ® Instant Relief
37000-341-93	2021-01-29	Head and Shoulders ® Instant Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pyrithione Zinc	ACTIVE INGREDIENT	R953O2RHZ5	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
Pyrithione Zinc	ACTIVE MOIETY	R953O2RHZ5	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
MAGNESIUM CARBONATE HYDROXIDE	INACTIVE INGREDIENT	YQO029V1L4	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
MENTHA ARVENSIS LEAF OIL	INACTIVE INGREDIENT	1AEY1M553N	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1
ZINC CARBONATE	INACTIVE INGREDIENT	EQR32Y7H0M	HEAD AND SHOULDERS INSTANT RELIEF (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R953O2RHZ5	PYRITHIONE ZINC	13463-41-7	PYRITHIONE ZINC

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37000-341-10	37000034110	10 mL in 1 POUCH (37000-341-10)	10 ml	2014-09-01	2022-08-14	No	No	Current
37000-341-38	37000034138	380 mL in 1 BOTTLE, PLASTIC (37000-341-38)	380 ml	2014-09-01	2022-08-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Head and Shoulders ® Instant Relief	The Procter & Gamble Manufacturing Company	2022-04-11	HUMAN OTC DRUG LABEL	9
Head and Shoulders ® Dual Sachets Instant Relief	The Procter & Gamble Manufacturing Company	2020-01-09	HUMAN OTC DRUG LABEL	4